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Emerging Weapons Against Generics Competition

Law360 (April 12, 2007, 12:00 AM EDT) -- Since enactment of the Hatch-Waxman Act in 1984, the U.S. Food and Drug Administration has been at the vortex of pharmaceutical patent enforcement.

As overseer of the so-called Orange Book, where pioneer patents are listed to provide notice to generics as well as to potentially block their market entry, the FDA has been pulled into patent disputes, both small and large, for over two decades.

Ill-equipped to mediate such disputes and reluctant to take sides, the FDA was forced nonetheless to adopt reforms in 2003 to...
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